4/3/2017 1 Sterile Compounding and Aseptic Technique: Reviewing the basics and preparing for USP <800>. Brenda Jensen CPhT, CNMT, MBA SDSHP Annual Conference April 7-8, 2017 Disclosure The views and opinions expressed are those of the speaker and are not endorsed by or affiliated with USP. Conflict of Interest I have no financial relationships with any commercial sponsor with a vested interest in this presentation Technician Learning Objectives 1. Review definitions related to compounding. 2. Explain proper hand-hygiene procedures and garbing order. 3. Discuss when to deactivate, decontaminate, clean and/or disinfect the PEC and C-PEC. 4. Locate the direct compounding area within the PEC and C-PEC.
Transcript
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Sterile Compounding and AsepticTechnique: Reviewing the basics and
preparing for USP <800>.
Brenda Jensen CPhT,CNMT, MBA
SDSHP AnnualConference
April 7-8, 2017
DisclosureThe views and opinions expressed are those of the
speaker and are not endorsed by or affiliated with USP.
Conflict of InterestI have no financial relationships with any commercial
sponsor with a vested interest in this presentation
Technician Learning Objectives1. Review definitions related to compounding.
3. Discuss when to deactivate, decontaminate, cleanand/or disinfect the PEC and C-PEC.
4. Locate the direct compounding area within the PECand C-PEC.
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Pharmacist Learning Objectives
1. Review new acronyms introduced in USP <800>.
2. Explain appropriate clean room behavior.
3. Identify requirements for environmentalmonitoring.
4. Determine how to establish a BUD.
United States Pharmacopeia (USP)USP <795> Nonsterile CompoundingUSP <797> Sterile CompoundingUSP <800> Nonsterile and Sterile Hazardous DrugsRelated chapters <71>, <85>, <1163>, etc.
Chapters numbered under 1000 are enforceable.Chapters numbered over 1000 are informational.
Shall or Must – RequirementShould - Recommendation
CSP – Compounded sterile preparationHD – Hazardous Drug (as defined by NIOSH)BUD – Beyond-use date
Ante-Room – ISO-7 or ISO-8 classified room wherehand hygiene and garbing occur.
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PEC - Primary engineering control is where CSPs arecompounded.Examples: LAFW and CAILAFW – Laminar Airflow WorkbenchCAI – Compounding Aseptic Isolator
SEC – Secondary engineering control is where PEC islocated.Examples: Positive pressure ISO-7 buffer room orsegregated compounding area (SCA).
C-PEC – Containment primary engineering control iswhere hazardous CSPs are compounded.Examples: BSC and CACI.BSC – Biological Safety CabinetCACI - Compounding Aseptic Containment Isolator
C-SEC - Containment secondary engineering control iswhere C-PEC is located.Examples: Negative pressure ISO-7 buffer room orcontainment segregated compounding area (C-SCA).
Technician Learning Assessment
An LAFW is an example of a C-PEC.
True or False
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False
An LAFW is an example of a PEC.
Pharmacist Learning Assessment
Compounding is performed in a C-SEClocated within a C-PEC.
True or False
False
Compounding is performed in a C-PEClocated within a C-SEC.
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Hand-Hygiene and Garbing
IIma
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Why is it important?
Individuals shall not work in sterile compounding areaswith
• Rashes• Sunburn• Weeping sores• Conjunctivitis• Active respiratory infection
Before entering ante-room or segregatedcompounding area remove
• Outer garments• Cosmetics• Hand, wrist, visible jewelry and piercings
(e.g., earrings, lipor eyebrow piercings)
• Nail polish• Artificial nails
Natural nails shall be kept neat and trimmed.
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Don garb dirtiest to cleanest
• Dedicated shoes or shoe covers on clean side of lineof demarcation. Dirty shoes should never touchclean side.
• Head and facial hair covers (e.g., beard covers)• Face masks• Eye shields.Eye shields are optional unless working with irritantssuch as germicidal disinfecting agents or whenpreparing hazardous drugs.
Perform hand hygieneHand washing procedure shall be performed byremoving debris from underneath fingernails using anail cleaner under running warm water followed byvigorous hand washing. Hands and forearms shall bewashed to the elbows for at least 30 seconds with soap(either nonantimicrobial or antimicrobial)and water while in the ante-room. The use ofantimicrobial scrub brushes is not recommendedbecause they can cause skin irritation and skin damage.Hands and forearms to the elbows will be completelydried using either lint-free disposable towels or anelectronic hand dryer.
After completion of hand washing, a nonshedding gownwith sleeves that fit snugly around the wrists andenclosed at the neck is donned. Gowns designated forbuffer room use shall be worn, and preferably theyshould be disposable. If reusable gowns are worn, theyshould be laundered appropriately for buffer room use.Once inside the buffer room or segregatedcompounding area, and prior to donning sterilepowder-free gloves, antiseptic hand cleansing shall beperformed using a waterless alcohol-based surgicalhand scrub with persistent activity. Hands are allowedto dry thoroughly before donning sterile gloves. Sterilegloves shall be the last item donned beforecompounding begins.
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Disinfection of contaminated gloved hands may beaccomplished by wiping or rubbing sterile 70% IPA to allcontact surface areas of the gloves and letting thegloved hands dry thoroughly.
Routine application of sterile 70% IPA to sterile glovesshall occur throughout the compounding process andwhenever nonsterile surfaces (e.g. vials, counter tops,chairs, carts) are touched.
Properly garbed and gloved compounding personnelwho are exposed to air quality that is either known orsuspected to be worse than ISO Class 7 shall re-garb PPEalong with washing their hands properly, performingantiseptic hand cleansing with a waterless alcohol-based surgical hand scrub, and donning sterile glovesupon reentering the ISO Class 7 buffer room.
When compounding personnel exit the ante-room orsegregated compounding area during a work shift, theexterior gown may be removed and retained in theante-room or segregated compounding area if notvisibly soiled, to be re-donned during that same workshift only.
However, shoe covers, hair and facial hair covers, facemasks/eye shields, and gloves shall be replaced withnew ones before re-entering the ante-room orsegregated compounding area, and proper handhygiene shall be performed.
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Doff garb on the clean side of line of demarcation inante-room or segregated compounding area.• Remove gloves and perform hand hygiene.• Remove gown and discard it, or hang it on hook if it
is to be reused within the same work shift.• Remove and discard mask, head cover, and beard
cover.• Remove shoe covers or shoes one at a time, ensuring
that uncovered foot is placed on the dirty side of theline of demarcation and perform hand hygiene again.(Remove and discard shoe covers every time theante-room or segregated compounding area isexited).
Additional PPE for Hazardous Compounding(per <800>)Don and doff within negative pressure buffer room orcontainment-segregated compounding area. HD PPEmust not be worn outside of negative pressure room.• Second set of shoe covers.• Chemo gown (may not be re-used)
Change per manufacturer or every 2-3 hours or aftersplash/spill
• Two pairs of chemotherapy gloves.Change per manufacturer or every 30 minutes or aftertear. Remove and discard outer glove while in BSC orCACI.
Technician Learning Assessment
Nails must be cleaned under runningwater before washing hands.
True or False
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True
Nails must be cleaned under runningwater before washing hands.
Pharmacist Learning Assessment
Pharmacists ____ need to garb to enter asegregated compounding area.
a. do b. do not
a. do
Pharmacists do need to garb to enter asegregated compounding area.
Protects the product or preparation. No personnelprotection.May be either horizontal or vertical air flow.
• BSC – Biological Safety Cabinet (C-PEC)Protects personnel. Used for hazardous drugs.Vertical air flow.Class II Type A2, B1, or B2Class III
Best to run PEC (LAFW) continuously. C-PEC (BSC) mustrun continuously (per <800>). LAFW/BSC must run 30minutes before use after being off.
Types of Primary Engineering ControlsRABS – Restricted Access Barrier System• CAI – Compounding Aseptic Isolator (PEC)
Protects the product or preparation. No personnelprotection.Vertical air flow, positive pressure.
• CACI – Compounding Aseptic Containment Isolator(C-PEC)Protects personnel. Used for hazardous drugs.Vertical air flow, negative pressure.
IsolatorContains an internal system to decontaminate
interior with sporicidal agent.
Cleaning and Disinfection of PECAt the beginning of each shift, before each batch, notlonger than 30 minutes following the previous surfacedisinfection when ongoing compounding activities areoccurring, after spills, and when surface contaminationis known or suspected.
Items shall be removed from areas to be cleaned, andsurfaces shall be cleaned by removing loose materialand residue from spills; e.g., remove water-solubleresidues with sterile water (for injection or irrigation)using low shedding wipes then wipe with a residue-freedisinfecting agent such as sterile 70% IPA, which isallowed to dry before compounding begins.
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Clean and disinfect PEC from cleanest to dirtiest usingoverlapping strokes and a new side of the cloth foreach location. Start by carefully cleaning the gridcovering the HEPA filter.
LAFW (horizontal air flow)Clean top then sides then work surface.
BSC and LAFW (vertical air flow)Clean back then then work surface.
CAI and CACI with the front panel closed:Follow manufacturer’s instructions or if not stated startwith the work chamber then move to the antechamber. Start by carefully cleaning the grid coveringthe HEPA filter being careful not to let any liquid enter.Clean back wall, sides, front wall and work surface.
Clean the gauntlet sleeves. Apply sterile gloves overgauntlet gloves. Sanitize gloves frequently with sterile70% isopropyl alcohol.
CAI with the front panel open:Follow manufacturer’s instructions or if not stated openfront panel and start with the work chamber then moveto the ante chamber. Start by carefully cleaning the gridcovering the HEPA filter being careful not to let anyliquid enter. Clean back wall, sides, areas under thework surface (if applicable), work surface, and front wall.
Clean the gauntlet sleeves. Apply sterile gloves overgauntlet gloves. Sanitize gloves frequently with sterile70% isopropyl alcohol.
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Use sporicidal agent on ISO-5 surfaces (including underthe work surface) at least monthly. Reminder: do notopen the front panel on CACI. Document cleaning anddisinfecting agents (and contact time as applicable).
Follow manufacturer’s recommendations on changinggauntlet sleeves and gauntlet gloves. Don’t forget todocument when this is done.
Need to know recovery time to return to ISO 5 afterCAI is turned off. CACI should never be turned off.Also need to know purge time before moving itemsfrom ante chamber to work chamber.
Deactivation, decontamination, cleaning anddisinfection of C-PEC (per <800>).
Deactivation renders a compound inactive. If nospecific information is available on SDS then use sodiumhypochlorite 5000 - 6000 ppm or other EPA registeredoxidizer.Decontamination removes inactivated substances. Mayuse 70% IPA, water, peroxide or sodium hypochlorite5000 – 6000 ppm.
C-PEC must be deactivated/decontaminated (andcleaned and disinfected) at least daily, any time a spilloccurs, before and after certification, any time voluntaryinterruption occurs, and if moved. Work surfacebetween compounding of different hazardous drugs.
Area under the work surface monthly.Document agents used and contact time.
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Ante-Room and Buffer Room andSegregated Compounding AreaClean and disinfect work surfaces at least daily.Clean and disinfect floors daily at a time when noaseptic operations are in progress. Mopping shall beperformed by trained personnel using approved agentsand procedures described in the written SOPs.
Using mop labeled ‘floor’ start at area furthest fromdoor (cleanest) moving to door (dirtiest). Buffer roomfirst then ante-room. Floor mops may be used in boththe buffer room and ante-room, but only in that order.
Clean and disinfect ceiling, walls, carts, equipmentexteriors storage and anything not covered in dailycleaning monthly.Ceiling first then walls, area furthest from door(cleanest) moving to door (dirtiest). Buffer room firstthen ante-room. Clean and disinfect equipmentexteriors, storage and any other areas not covered indaily cleaning/disinfection. Must be done all in one daywhen no aseptic operations are in progress. Documentdate, time, cleaning agent, disinfectant and contacttime.
Use sporicidal agent on all surfaces at least monthly.
A full cleaning is required anytime the clean room iscompromised including
• Inappropriate garbing or staging• When HEPA fans are off (for any reason including
maintenance and power outages)• Walls/ceiling have been opened
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Additional requirements for C-SEC (per <800>)All areas where hazardous drugs are handled and allreusable equipment and devices must be deactivated,decontaminated, cleaned and disinfected.
It is incumbent on compounding personnel to ensurethat such cleaning is performed properly. Schedules ofuse and methods of application shall be in accordancewith written SOPs and followed by custodial orcompounding personnel.
Environmental MonitoringDaily• Temperature (< or equal to 77F ideally < 68F)• Humidity (recommend < 60%)• Pressures
Positive (non-HD rooms) at least 0.02Negative (HD rooms) -0.01 to -0.03
• Refrigerator/Freezer temperaturesRefrigerators 2 to 8C (36 to 46F)Freezers -25 to -10C (-13 to 14F)
PeriodicSurface testing in all ISO-classified and segregatedcompounding areas.
Use TSA with lecithin and polysorbate 80.Incubate 30-35C for 48 to 72 hours.
Every 6 monthsNonviable air counts under dynamic conditions.
Viable air counts (400-1000L volumetric air sample)using TSA (and MEA for high-risk) under dynamicconditions with growth identified/reported as CFU percubic meter.Recommended action levelsISO 5 > 1 cfuISO 7 > 10 cfuISO 8 > 100 cfu
Air changes of at least 30 (15 may come from the PEC).
Regardless of the number of cfu identified in thecompounding facility, further corrective actions willbe dictated by the identification of microorganismsrecovered (at least the genus level) by an appropriatecredentialed laboratory of any microbial bioburdencaptured as a cfu using an impaction air sampler.Highly pathogenic microorganisms (e.g., Gram-negative rods, coagulase positive staphylococcus,molds and yeasts) can be potentially fatal to patientsreceiving CSPs and shall be immediately remedied,regardless of cfu count, with the assistance of acompetent microbiologist, infection controlprofessional, or industrial hygienist.
Technician Learning Assessment
__________ renders a drug inactive.
a. cleaningb. disinfectionc. decontaminationd. deactivation
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d. deactivation
Deactivation renders a drug inactive.
Pharmacist Learning Assessment
Ante-room air sample reveals 1 cfu ofcoag + s.aureus. Is this a problem?
Yes No
YesHighly pathogenic microorganisms (e.g.,Gram-negative rods, coagulase positivestaphylococcus, molds and yeasts) can bepotentially fatal to patients receiving CSPsand shall be immediately remedied,regardless of cfu count, with theassistance of a competent microbiologist,infection control professional, orindustrial hygienist.
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StagingRemove supplies from shipping cartons. No shipping orother external cartons may be taken into the bufferroom or segregated compounding area (or C-SCA).
Stage equipment and supplies by wiping with sterile70% IPA and a low lint wipe before entering each ISOarea.
When sterile supplies are received in sealed pouchesdesigned to keep them sterile until opening, the sterilesupplies may be removed from the covering pouches asthe supplies are introduced into the ISO Class 5 PECwithout the need to disinfect the individual items.
Clean room behavior and aseptic technique reminders
• First air shall touch critical points of vials, syringes,needles, etc.
• Do not touch critical points orallow critical points to touchnonsterile surfaces.
• Avoid shadowing.Hands/objects should never comebetween critical point andHEPA filter.
DCA 6 inches from front DCA 4 inchesabove work surface
Clean room behavior and aseptic technique reminders
• Keep trash out of direct compounding area (DCA).• Use slow purposeful movements.• Disinfect gloves every time they leave the PEC.• Work in the direct compounding area (DCA).• Do not rest hands/arms on DCA.• Avoid sneezing, coughing, excessive talking.• Keep head from entering PEC.• Compound one preparation at a time.
Disinfecting vials, injection ports, etc.Wiping with small sterile 70% IPA swabs that arecommercially available in individual foil-sealedpackages is preferred for disinfecting entry points onbags and vials, allowing the IPA to dry before piercingstoppers with sterile needles and breaking necks ofampuls. The surface of the sterile 70% IPA swabs usedfor disinfecting entry points of sterile packages anddevices shall not contact any other object beforecontacting the surface of the entry point. Sterile 70%IPA wetted gauze pads or other particle-generatingmaterial shall not be used to disinfect the sterile entrypoints of packages and devices.
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Additional requirements for handling HDs (per <800>)• Wipe down HD containers to reduce the amount of
contamination introduced into the C-PEC.• Supplemental engineering controls [CSTD] should be
used when the dosage form allows. CSTDs must beused when administering antineoplastic HDs whenthe dosage form allows.
• When CSTD not available, use negative pressuretechnique to withdraw liquid from vials.
• Seal in impervious plastic bags with cautionary label.• Transport in impact-resistant and/or water-tight
containers. Do not use pneumatic tubes forhazardous liquids or antineoplastic drugs.
Single dose vials and containers opened outside an ISO 5environment may be used up to ONE hour. This includesSodium Chloride, Sterile Water for Injection and SterileWater for Irrigation.
Single dose vials and containers opened inside an ISO 5environment may be used up to SIX hours.
Open ampules must be filtered and used immediately.
Multi-dose vials (including compounded MDV) may beused up to 28 days unless specified otherwise bymanufacturer. Vials must be labeled.
HD Storage(per <800>)Antineoplastic hazardous drugs requiring manipulationother than counting or repackaging of final dosageforms and any hazardous drug API must be storedseparately from non-hazardous drugs in a manner thatprevents contamination and personnel exposure.
These hazardous drugs must be stored in an externallyventilated, negative-pressure room with at least 12 airchanges per hour (ACPH). Non-antineoplastic,reproductive risk only, and final dosage forms ofantineoplastic hazardous drugs may be stored withother inventory if permitted by entity policy.
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Definition of low-, medium- and high-risk and USP<797> storage
Low-Risk compounding involves not more than threecommercially manufactured packages of sterileproducts and not more than two entries into any onesterile container or package.
Controlled Room Temp 20-25C or 68-77F <= 48 hrsCold Temp 2-8C or 36-46F <= 14 daysFrozen -25 to -10C or -13 to 14F <= 45 days
Medium-Risk compounding involves more than threecommercially manufactured packages of sterileproducts, more than two entries into any one sterilecontainer or package, complex manipulations orunusually long duration.
Controlled Room Temp 20-25C or 68-77F <= 30 hrsCold Temp 2-8C or 36-46F <= 9 daysFrozen -25 to -10C or -13 to 14F <= 45 days
Note: Repackaging and biologics have their own rules.
High-Risk (1) compounding involves nonsterilecomponents or devices or (2) compounding personnelare improperly garbed or gloved or (3) any of thefollowing are exposed to air quality worse than ISOClass 5 for more than 1 hour: sterile contents ofcommercially manufactured products, CSPs that lackeffective antimicrobial preservatives, and sterilesurfaces of devices and containers for the preparation,transfer, sterilization, and packaging of CSPs.
Controlled Room Temp 20-25C or 68-77F <= 24hrsCold Temp 2-8C or 36-46F <= 3 daysFrozen -25 to -10C or -13 to 14F <= 45 days.
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Immediate-use is for emergency or immediate patientadministration of a CSP where patient is subject to riskfrom delays in therapy.• Nonhazardous low risk only.• No batch compounding.• No Storage. Under continuous supervision.• Must follow aseptic technique• Prepared & administration started within one hour.• Must be discarded if administration has not begun
within 1 hour from the start of preparation.• If not prepared/witnessed by administrator, must be
labeled with names/amounts of ingredients, initialsof the preparer and the exact 1-hour BUD and time.
Low-risk with 12-hour BUD if the PEC is a CAI/CACIthat does not meet the exception requirements orLAFW/BSC that is not located within an ISO Class 7buffer room.• Low-risk nonhazardous and radiopharmaceutical
only.• Pursuant to a physician's order for a specific patient.• PEC located in segregated compounding area
restricted to sterile compounding activities thatminimize the risk of contamination.
• segregated compounding area shall be located awayfrom unsealed windows or doors that connect tothe outdoors, high traffic areas, construction sites,warehouses, food preparation areas.
Low-risk with 12-hour BUD
Personnel shall follow <797>• Hand hygiene and garbing• Cleaning and disinfection• Aseptic technique• Environmental monitoring• Training and competency
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CAI/CACI Exception RequirementsCAI/CACI outside of an ISO 7 buffer room needsdocumentation from manufacturer and certificationcompany (every six months) :1) CAI shall provide isolation from the room andmaintain ISO Class 5 during dynamic operatingconditions, including transferring ingredients,components, and devices into and out of the isolatorand during preparation of CSPs.2) Particle counts sampled approximately 6 to 12inches upstream of the critical exposure site shallmaintain ISO Class 5 levels during compoundingoperations.
3) Not more than 3520 particles (0.5 mm and larger)per m3 shall be counted during material transfer, withthe particle counter probe located as near to thetransfer door as possible without obstructing thetransfer.
Make sure documentation from manufacturer is foryour specific model.
CAI/CACI Exception Requirements• Only authorized personnel and materials in thecompounding area.• Presterilization procedures for high-risk, such asweighing & mixing, shall be completed in no worsethan an ISO Class 8 environment.• PECs located out of traffic patterns/air currents.• CACIs for hazardous must be in a compounding areathat maintains a minimum negative pressure of 0.01-inch water column and have a minimum of 12 ACPHs.• Appropriate personnel protective equipment (PPE)shall be worn.
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When CAIs and CACIs are the source of the ISO Class 5environment, the garbing and gloving requirements forcompounding personnel should be as described above,unless the manufacturer can provide writtendocumentation based on validated environmentaltesting that any component(s) of PPE or personnelcleansing are not required.
When is a sterility test needed?• All risk levels require a sterility test when exceeding
USP <797> storage limits.• All high-risk level CSPs that are prepared in groups of
more than 25 identical individual single-dose packagesor in multiple-dose vials for administration to multiplepatients or that are exposed longer than 12 hours at2° to 8° and longer than 6 hours at warmer than 8°before they are sterilized shall meet the sterility testbefore they are dispensed or administered.
• [NOTE—Sterility tests for autoclaved CSPs are notrequired unless they are prepared in batches >25]Sterility Tests must be comply with USP <71>
• Extending BUD requires sterility AND stabilityassurance.
• Stability is not the same as potency.
• BUDs and expiration dates are not the same.-Expiration dates for the chemical and physicalstability of manufactured products are determinedfrom rigorous testing.-BUDs for compounded preparations are assignedon the basis of direct testing or extrapolation fromreliable literature sources and other documentation.
.
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Technician Learning Assessment
The direct compounding area in a BSC is__________.
a. six inches from the frontb. four inches from the frontc. six inches above the surfaced. four inches above the surface
d. four inches above the surface
The direct compounding area in a BSC isfour inches above the surface.
Pharmacist Learning Assessment
Drug X has a stability (in a syringe) of 15days refrigerated. One vial is used toprepare four pediatric syringes. What BUDshould be assigned?a. 15 daysb. 14 daysc. 9 daysd. 3 days
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c. 9 days
Use the shorter of stability (15 days) andsterility assurance (9 days for medium-risk).
Training and CompetencyInitially- GFS x 3 with zero cfusInitially & Annually for Low-,Medium-riskInitially & Q6mo for High-risk• Didactic review/test and media-fill• GFS after garbing and after completing media-fill.
(One plate for each hand. Total of 3 or fewer cfus.)• Visual observation
-Hand Hygiene and Garbing (Appendix III)-Aseptic Technique (Appendix IV)-Cleaning and Disinfection (Appendix V)
• Post media fill surface test (3 or fewer cfus) tovalidate staging and disinfection process.
Media-fill tests represent the most challenging orstressful conditions actually encountered by thepersonnel being evaluated when they prepareparticular risk level CSPs and when sterilizing high-risklevel CSPs.
Compounding personnel who fail written tests orwhose media-fill test vials result in gross microbialcolonization shall be immediately re-instructed and re-evaluated by expert compounding personnel to ensurecorrection of all aseptic practice deficiencies.
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Training/Competency requirements for HDs (per <800>)•All personnel who handle HDs or who performcustodial waste removal or cleaning activities must betrained based on job functions. Training must occurbefore independently handling HDs.•Personnel must be trained prior to the introductionof a new HD or new equipment and prior to a new orsignificant change in process or SOP.•Effectiveness of training must be demonstrated.•Competency must be reassessed at least annually.•All training and competency assessments must bedocumented according to OSHA standards and otherapplicable laws and regulations.
Training/Competency requirements for HDs (per <800>)• Overview of HDs in use and their risks• Use of Safety Data Sheets• Storage• Review of SOPs related to handling of HDs• Use of equipment and devices• Use of PPE including use of NIOSH respirators• Prevention of HD contamination• Labeling and transport• Disposal of HDs and trace-contaminated materials• Spill management and use of a spill kit• Response to known or suspected HD exposure
Additional requirements for HDs (per <800>)
Must maintain a list of HDs, which must include anyitems on the current NIOSH list. List must be reviewedat least every 12 months.
Drugs on the NIOSH list that must follow therequirements of USP <800> include:— Any HD API— Any antineoplastic requiring HD manipulation
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Additional requirements for HDs (per <800>)• Drugs on the NIOSH list that do not have to follow allthe containment requirements of USP <800> if anassessment of risk is performed and implementedinclude:— Final dosage forms of compounded HD preparationsand conventionally manufactured HD products,including antineoplastic dosage forms that do notrequire any further manipulation other than countingor repackaging (unless required by the manufacturer).
• For dosage forms of other HDs on the NIOSH list, theentity may perform an assessment of risk to determinealternative containment strategies and/work practices.
Additional requirements for HDs (per <800>)The assessment of risk must consider the following:• Type of HD• Dosage form• Risk of exposure• Packaging• ManipulationIf an assessment of risk approach is taken, the entity mustdocument what alternative containment strategies and/orwork practices are being employed for specific dosageforms to minimize occupational exposure. If used, theassessment of risk must be reviewed at least every 12months and the review documented.
Additional requirements for HDs (per <800>>)All personnel who may be required to clean up a spillof hazardous drugs must receive proper training inspill management and the use of PPE and NIOSH-certified respirators.
Spills must be contained and cleaned immediatelyonly by qualified personnel with appropriate PPE.
Qualified personnel must be available at all timeswhile hazardous drugs are being handled.
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Additional requirements for HDs (per <800>>)Signs must be available for restricting access to thespill area.
Spill kits containing all of the materials needed toclean hazardous drug spills must be readily available inall areas where hazardous drugs are routinelyhandled.
SDS must be retrievable in hazardous drug handlingareas.
All spill materials must be disposed of as hazardouswaste.
Additional requirements for HDs (per <800>)EPA provides information on environmental hazards.P- and U-listed drugs must be segregated anddisposed of as hazardous waste to comply with EPAregulations. Note that these drugs are different thanthe drugs on the NIOSH list. EPA defines hazardous asrelated to the disposal of hazardous drugs so aims toprotect the environment. Section 13 of the SafetyData Sheet lists disposal considerations. Keep in mindthat state and local laws may be even more restrictive.
DOT defines hazardous from a shipping perspective.Section 14 of the Safety Data Sheet lists transportinformation. Also check vendor requirements.
ReferenceUnited States Pharmacopeia USP 39 - NF 34
